Eric Gerfen Email & Phone Number

Valencia, California

Oversee all Failure Analysis lab operations (Implants & Externals) and implant reliability projects. Generate Engineering Reports for reliability projects performed in the lab. Run the bi-weekly Explant Review Board; prepare and distribute summaries and maintain attendance logs.Manage lab operations and workflow assignments to ensure compliance with company goals and commitments and to ensure high standards of workmanship are maintained. Ensure quality analysis of explanted devices and their components, OR returned devices and Implant tools is performed. Support Failure Analysis of failed production parts as needed.Generate Engineering Test Plans for the execution of Shelf Life and Distribution studies in compliance with ISO 11607-1 and EN 45502-1 10.1 and 10.2. Oversee the execution of Shelf Life and Distribution studies per relevant ASTM standards. Write Engineering Reports summarizing Shelf Life and Distribution studies for the purposes of regulatory submission.Evaluate group metrics and ensure compliance with company goals and commitments. Provide weekly, monthly or as needed reviews to management regarding metrics, work flow and lab operations. Review return information for trends which are then elevated and discussed with appropriate company personnel. Provide direction to subordinates based on quality procedures, general policies, management guidelines and company commitments. Delegate duties and responsibilities to subordinates as needed. Review training plans and make adjustments as appropriate.Recommend corrective actions where necessary and participate in the development of new test methods, procedures, and systems. Review, revise and develop new quality procedures and documents. Maintain Failure Analysis database integrity; perform audits of the database for data accuracy. Construct queries to provide Engineering and R&D with data as requested.

Valencia, California

Oversee all Implant Failure Analysis lab operations and implant reliability projects. Generate Engineering Reports for reliability projects performed in the lab. Run the bi-weekly Explant Review Board; prepare and distribute summaries and maintain attendance logs.Manage lab operations and workflow assignments to ensure compliance with company goals and commitments and to ensure high standards of workmanship are maintained. Ensure quality analysis of explanted devices and their components, OR returned devices and Implant tools is performed. Support Failure Analysis of failed production parts as needed.Generate Engineering Test Plans for the execution of Shelf Life and Distribution studies in compliance with ISO 11607-1 and EN 45502-1 10.1 and 10.2. Oversee the execution of Shelf Life and Distribution studies per relevant ASTM standards. Write Engineering Reports summarizing Shelf Life and Distribution studies for the purposes of regulatory submission.Evaluate group metrics and ensure compliance with company goals and commitments. Provide weekly, monthly or as needed reviews to management regarding metrics, work flow and lab operations. Review return information for trends which are then elevated and discussed with appropriate company personnel. Provide direction to subordinates based on quality procedures, general policies, management guidelines and company commitments. Delegate duties and responsibilities to subordinates as needed. Review training plans and make adjustments as appropriate.Recommend corrective actions where necessary and participate in the development of new test methods, procedures, and systems. Review, revise and develop new quality procedures and documents. Maintain Failure Analysis database integrity; perform audits of the database for data accuracy. Construct queries to provide Engineering and R&D with data as requested.

Perform Failure Analysis on returned Implantable Medical Devices. Perform Electronic and Hermetic testing, deconstruction and root cause analysis using common lab equipment, x-ray, fluorescence microscope, thermal chambers, IR camera, SEM analysis.

Execute Validation and Verification testing, Long Term Life Testing, Reliability Testing, Environmental Testing. Design and build Pneumatic and Hydraulic test systems used for the long term test and evaluation of product reliability.

Perform destructive Quality Control testing on Subcutaneous Glucose Sensors. Worked in class 10,000 (ISO Class 7) Clean Room environment. Followed Good Documentation Practices in all facets of duties.

Science Studies

Certificate, Electronics

Activities and Societies: Student Leader